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Sponsored by: |
Saint Francis Memorial Hospital |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014092 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interleukin-2 and interferon alfa stimulate a person's white blood cells to kill cancer cells or may interfere with the growth of cancer cells. Combining chemotherapy with biological therapies may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of temozolomide followed by sargramostim, interleukin-2, and interferon alfa in treating patients who have stage IV melanoma that cannot be treated with surgery.
Condition | Intervention | Phase |
---|---|---|
Melanoma (Skin) |
Biological: aldesleukin Biological: recombinant interferon alfa Biological: sargramostim Drug: temozolomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Metastatic Malignant Melanoma With Chemobiotherapy With Temozolomide, GM-CSF, IL2, and Interferon Alfa-2b Phase II Trial |
Study Start Date: | December 1999 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide on days 1-5, and sargramostim (GM-CSF), interleukin-2, and interferon alfa subcutaneously on days 6-17. Treatment repeats every 28 days for 4-8 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable or responsive disease after 8 courses of therapy may receive additional therapy at investigators discretion.
Quality of life is assessed at baseline, every 8 weeks during study, and then at 1 month after study.
Patients are followed at 1 month, every 3 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 2 years.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
John Wayne Cancer Institute at Saint John's Health Center | |
Santa Monica, California, United States, 90404 | |
Saint Francis Memorial Hospital | |
San Francisco, California, United States, 94109 | |
United States, Colorado | |
University of Colorado Cancer Center at University of Colorado Health Sciences Center | |
Aurora, Colorado, United States, 80010 |
Study Chair: | Lynn E. Spitler, MD | Northern California Melanoma Center at St. Francis Memorial Hospital |
Study ID Numbers: | CDR0000067958, SFMH-BB-IND-5301, NCI-V00-1591 |
Study First Received: | April 10, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00014092 History of Changes |
Health Authority: | United States: Federal Government |
stage IV melanoma recurrent melanoma |
Interferon-alpha Interferon Type I, Recombinant Anti-HIV Agents Immunologic Factors Interferons Angiogenesis Inhibitors Antiviral Agents Temozolomide Recurrence Melanoma Neuroendocrine Tumors |
Neuroectodermal Tumors Aldesleukin Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Nevus, Pigmented Neuroepithelioma Antineoplastic Agents, Alkylating Nevus Interferon Alfa-2a Alkylating Agents Interferon Alfa-2b |
Anti-Infective Agents Interferon Type I, Recombinant Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Melanoma Anti-Retroviral Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Nevi and Melanomas Angiogenesis Modulating Agents Growth Inhibitors Alkylating Agents |
Interferon-alpha Anti-HIV Agents Neoplasms by Histologic Type Growth Substances Interferons Temozolomide Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Aldesleukin Antineoplastic Agents, Alkylating Interferon Alfa-2a |